某院148例严重药品不良反应报告分析

Report analysis of 148 cases of severe adverse drug reactions in a hospital

目的分析严重药品不良反应(SADR)的特点和规律,挖掘其预警信号,为临床安全用药提供参考。方法收集某三甲医院2012-2019年上报的148例SADR报告,从患者年龄、性别、药品种类、给药途径、SADR累及器官或系统及临床表现、转归情况等方面进行统计与分析。结果在148例SADR报告中,男女比例为1.18∶1,其中>60岁患者人数最多,占比为52.03%;涉及药品以抗肿瘤药物(60.81%)和抗菌药物(16.22%)为主;给药途径中以静脉滴注比例最高(84.46%);累及系统/器官以血液系统损害最为常见(38.55%);大多数(87.84%)SADR经停药或采取积极治疗措施后可痊愈或好转。结论临床应加强ADR的监测,尤其要重视SADR监测和报告,规范抗肿瘤药物及抗菌药物使用,实施风险预警,保障患者用药安全。

Objective To provide references for clinical rational drug use by analyzing the characteristics and regularity of 148 cases of severe adverse drug reactions(SADR)from a tertiary hospital in 2012-2019,to excavate warning signals.Methods One hundred and forty-eight cases of SADR in a Third Grade hospital during 2012 to 2019 were collected.The gender,age,types of drugs,route of administration,organ and(or systems)involved,clinical manifestations were summarized and analyzed.Results The gender proportion(male∶female)in 148 SADR cases was 1.18∶1.The number of patients aged>60 years was the largest,accounting for 52.03%.In the classification of the drugs,the most SADR cases were caused by antitumor drugs(60.81%)and antibacterial drugs(16.22%).Intravenous infusion was the most leading way to cause SADR,accounting for 84.46%.The main clinical manifestation of SADR was digestive system damage.87.84%prognosis of SADR had good results.Conclusion In order to ensure patients safety,hospital should pay more attention to reporting and monitoring of ADR in clinic,especiauy SADR.Antitumor and antibacterial drugs should be rationally used to reduce the incidence of SADR and ensure patients safety.